Frequently Asked Questions, "About Pharmacovigilance system"

Q: Are the generic marketing authorization holders (MAHs) demanded to have a Pharmacovigilance system?

A: Yes. Every MAH is responsible for the safety monitoring of its medicinal products to safe guard patient, thus need a Pharmacovigilance system.



Q: My company is a small one it is a MAH of only few medicinal products (e.g. 2 or 3 products), should this company have a Pharmacovigilance system?

A: Every MAH should take its responsibility for the safety monitoring of its medicinal products to safe guard patient. Patients have all the right to take safe & effective medicinal product whether it is authorized for small or large company, MAH must not compromise on patient safety. However, it is acknowledged that small companies may not have sufficient resource available in-house to address the requirements for a QPPV and appropriate back-up arrangements. Therefore, MAH may transfer any or all pharmacovigilance tasks and functions, including the role of the QPPV, to another organization i.e outsourcing (optional) this may be more cost-effective. The ultimate responsibility for the fulfillment of pharmacovigilance requirements always resides with the MAH.



Q: Should the multinational MAH have a complete phramacovigilance system in Egypt office?

A: All MAHs must have an appropriate system of pharmacovigilance in place. It is understood that for Multinational MAH/Applicant the Pharmacovigilance system in Egypt functions as a part of its global pharmacovigilance system and integrate with it. Accordingly, these MAHs/Applicants should provide clear illustration of the key elements of both global pharmacovigilance system and Egypt Pharmacovigilance system, highlighting the role of Egypt QPPV/LSR, which pharmacovigilance activities are carried out in Egypt, which are carried out in the headquarter/globally and how they integrate together. Multinational MAH are required to submit both of PSMF and PSSF.



Q: I am agent of Multinational MAH of certain product and I am the MAH in Egypt, who will be responsible for Pharmacovigilance tasks in Egypt?

A: Always the MAH in Egypt is the one who is legally responsible for Pharmacovigilance tasks of course in cooperation with this Multinational MAH. However, if this Multinational MAH has a scientific office in Egypt it is highly recommended that this scientific office become the Pharmacovigilance representative, being not the MAH in Egypt; an official Pharmacovigilance outsourcing agreement will be needed. The rational is that the exchange of safety information & Pharmacovigilance systems integration will be more reliable between the Multinational MAH and its scientific office in Egypt compared to that with a third party agent.



Q: Are the toll pharmaceutical companies required to have a Pharmacovigilance system?

A: Yes. Every MAH is responsible for the safety monitoring of its medicinal products to safe guard patient, thus need a Pharmacovigilance system. However, it is acknowledged that small companies may not have sufficient resource available in-house to address the requirements for a QPPV and appropriate back-up arrangements. Therefore, MAH may transfer any or all pharmacovigilance tasks and functions, including the role of the QPPV, to another organization i.e outsourcing (optional) this may be more cost-effective. The ultimate responsibility for the fulfillment of pharmacovigilance requirements always resides with the MAH.



Q: Are the distributors required to have a Pharmacovigilance system?

A: Only if they are MAH to any human medicine or biological product they are required to have Pharmacovigilance system in house or Pharmacovigilance outsourcing agreement with third party. This does not apply for distributors which are NOT MAHs.



Q: My company is still under construction, should I have a Pharmacovigilance system?

A: Yes, company under construction should start building its Pharmacovigilance system as a part of its construction because submitting the PSMF and performing Pharmacovigilance activities is one of the requirements to register its products.